Disclosed is a device which simultaneously provides the advantages of comfort and flexibility while also providing a highly secure position for tubing and lumens extending from a percutaneous site. In one embodiment, the device is provided for use with patients fitted with central venous access devices (CVAD), gastronomy tubes, or chest tubes. CVADs allow frequent access to the veins without deep needle sticks. Examples of CVADs include central venous catheters (CVC) or central lines, surgically implanted ports, and peripherally inserted central catheters (PICC).
A central venous catheter (CVC) is surgically implanted into a large vein in the neck, chest or groin. A peripherally inserted central catheter (PICC) is inserted into one of the peripheral veins in the upper amt. In addition to the tube inserted into the vein, CVCs and PICCs include lumens. The tube extending from the percutaneous site is often supplied with a central hub or manifold for connection to one or multiple lumens. The lumens, which may or may not be connected to an infusion pump, are used to administer medication or fluids, obtain blood tests, and directly obtain cardiovascular measurements such as the central venous pressure. Venous access devices typically remain in place for extended periods of time. The percutaneous site is dressed and requires routine observation and attention by medical personnel. Typically, while the lumens are not in use they are secured by adhesive tape to the patient to prevent any accidental contact, unwanted movement, and inadvertent removal. The repeated removal of the tape often causes irritation.
When CVADs are used with babies and small children, there is an increased risk that the intravenous tubes and the lumens can be dislodged and contaminated, thus increasing the possibility of bloodstream infections. The disclosed device provides a comfortable fit, is adjustable, allows access to the dressing, redirects and protects the intravenous tubes, and secures the lumens from inadvertent tampering without the use of tape or irritating adhesives.
U.S. Pat. No. 4,470,410 to Elliott discloses a protective retaining device for application to the site of an intravenous or catheter intervention system to protect the site and to retain the tubing in a position proximate the body. The device is comprised of an elongated flexible sleeve. An opening is provided over the intervention site. The sleeve has releasable hook type fasteners, such as Velcro®, and includes a fastenable flap covering the opening. Tubing is secured by the flexible material of the sleeve against the body of the patient.
U.S. Pat. No. 5,897,519 to Shesol, et al. discloses a device for holding tubing in place in a variety of locations. The device comprises a sleeve having a window. The device is fastened by releasable Velcro®. Strips are provided on opposite sides of the window for securing the tubing.
U.S. Pat. No. 6,267,115 to Marshel discloses a flexible sleeve that surrounds an extremity where an intravenous catheter enters a vein. The sleeve is secured with Velcro® and an adhesive layer which adheres to the patient's skin. An opening in the sleeve provides a passage for the tubing. A flexible tab secures the tubing to the sleeve by an adhesive. The device does not include a transparent window.
U.S. Patent Application Publication No. 2005/0020977 to Eldridge, et al. discloses a guard for covering an infusion site while allowing visual inspection. The device is secured with Velcro®. The device provides an opening positioned over the infusion site. A resilient flap having a flexible window is secured to the device over the opening. The flap is also used to secure the tubing. The device does not include a way to redirect tubing or secure lumens.
U.S. Patent Application Publication No. 2013/0012883 to Fitzgerald, et al. discloses a sleeve for protecting and securing catheter dressings and tubes. Velcro® is provided to secure the device to the patient. A slit in the body of the device provides a passage for tubing. A strap secures the tubing against the exterior surface of the device. The device also may include a transparent window positioned over the dressing site.
Therefore, there is a need for a tamper resistant, intravenous protective device that is easily and adjustably secured to a patient. There is also a need for a flexible sleeve which provides comfort to the patient and provides for flexibility to promote physical activity. There is also a need for a device that secures percutaneous tubes and lumens from inadvertent tampering and dislodgment while allowing ease of access for frequent medication.